GLYXAMBI TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

EMPAGLIFLOZIN; LINAGLIPTIN

Disponible depuis:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Code ATC:

A10BD19

DCI (Dénomination commune internationale):

LINAGLIPTIN AND EMPAGLIFLOZIN

Dosage:

25MG; 5MG

forme pharmaceutique:

TABLET

Composition:

EMPAGLIFLOZIN 25MG; LINAGLIPTIN 5MG

Mode d'administration:

ORAL

Unités en paquet:

30

Type d'ordonnance:

Prescription

Domaine thérapeutique:

DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0258690002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2021-12-09

Résumé des caractéristiques du produit

_ _
_Glyxambi_
_TM_
_ Product Monograph _
_ Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
GLYXAMBI
TM
empagliflozin and linagliptin tablets
10 mg/5 mg and 25 mg/5 mg
ATC Code: A10BD19
Combinations of oral blood glucose lowering drugs
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Rd
Burlington, ON L7L 5H4
# 0285-18
Date of Revision:
APR 04, 2023
Submission Control No: 269916
_Glyxambi_
_™_
_ is a trademark of Boehringer Ingelheim International GmbH, used
under license. _
_ _
_Glyxambi_
_TM_
_ Product Monograph _
_ Page 2 of 56 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................23
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STABILITY
..........................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.......................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................32
PART II: SCIENTIFIC INFORMATION
..........